CEN/TC 204

Registration number (WIID)Project No.TitleStatus
76162EN 556-2:2024Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devicesStandarts spēkā
35152EN ISO 13408-5:2011Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)Standarts spēkā
72112LVS EN ISO 25424:2020/A1:2022Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)Standarts spēkā
72619EN ISO 11137-1:2026Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2025)Standarts spēkā
58413EN ISO 11737-1:2018Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product (ISO/DIS 11737-1:2016)Standarts spēkā
71095LVS EN ISO 17665:2024Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)Standarts spēkā
35151LVS EN ISO 13408-3:2011Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)Standarts spēkā
58414EN ISO 13408-2:2018Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO/DIS 13408-2:2017)Standarts spēkā
76163EN 556-1:2024Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devicesStandarts spēkā
76989LVS EN ISO 17664-2:2024Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)Standarts spēkā
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